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Efficacy of Ciclesonide and Fluticasone Propionate in Adult Patients With Moderate and Severe Persistent Asthma (18 to 75 y) (BY9010/IT-101)

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ciclesonide
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Ciclesonide, Fluticasone propionate

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria: Written informed consent History of bronchial asthma for at least 6 months Pre-treatment with CFC-beclomethasone dipropionate (CFC-BDP) ≥ 1000 mcg/day or equivalent and a long-acting beta agonist (LABA) either in free or fixed combination FEV1 ≥ 80% of predicted Main Exclusion Criteria: Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids or contraindications for the use of LABAs COPD Smoking with ≥10 pack-years Pregnancy Intention to become pregnant during the course of the study Breast feeding Lack of safe contraception

Sites / Locations

  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
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Outcomes

Primary Outcome Measures

number of patients with candidiasis of the oropharynx or hoarseness.

Secondary Outcome Measures

inhaled Corticosteroids Questionnaire (ICQ)
proportion of cases of candidiasis of the oropharynx or
hoarseness at each visit Secondary variables
FEV1, FVC, PEF from spirometry
morning and evening PEF from diaries
diurnal PEF fluctuation
onset of treatment effect
percent days on which patient perceived asthma control
percent of nocturnal awakening-free days
percent of rescue medication free days
percent symptom free days
asthma symptom score
use of rescue medication
time to first asthma exacerbation
number of patients with an asthma exacerbation
AQLQ
number of patients with candidiasis of the oropharynx or hoarseness by severity
physical examination, ECG
vital sings
adverse events
standard laboratory work-up
morning serum cortisol
skin bruising.

Full Information

First Posted
September 12, 2005
Last Updated
December 1, 2016
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00163319
Brief Title
Efficacy of Ciclesonide and Fluticasone Propionate in Adult Patients With Moderate and Severe Persistent Asthma (18 to 75 y) (BY9010/IT-101)
Official Title
Comparison of Inhaled Ciclesonide (640 mcg/Day) and Fluticasone Propionate (1000 mcg/Day) in Patients With Moderate and Severe Persistent Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

Brief Summary
The aim of the study is to compare the safety and efficacy of ciclesonide versus fluticasone propionate on the lung function, symptoms, use of rescue medication, and occurrence of side effects (such as candidiasis, hoarseness) in adults with persistent asthma. Ciclesonide will be inhaled twice daily at one dose level; fluticasone propionate will be inhaled twice daily at one dose level. The study duration consists of a baseline period (2 weeks) and a treatment period (24 weeks). The study will provide further data on safety and tolerability of ciclesonide.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Ciclesonide, Fluticasone propionate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
500 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ciclesonide
Primary Outcome Measure Information:
Title
number of patients with candidiasis of the oropharynx or hoarseness.
Secondary Outcome Measure Information:
Title
inhaled Corticosteroids Questionnaire (ICQ)
Title
proportion of cases of candidiasis of the oropharynx or
Title
hoarseness at each visit Secondary variables
Title
FEV1, FVC, PEF from spirometry
Title
morning and evening PEF from diaries
Title
diurnal PEF fluctuation
Title
onset of treatment effect
Title
percent days on which patient perceived asthma control
Title
percent of nocturnal awakening-free days
Title
percent of rescue medication free days
Title
percent symptom free days
Title
asthma symptom score
Title
use of rescue medication
Title
time to first asthma exacerbation
Title
number of patients with an asthma exacerbation
Title
AQLQ
Title
number of patients with candidiasis of the oropharynx or hoarseness by severity
Title
physical examination, ECG
Title
vital sings
Title
adverse events
Title
standard laboratory work-up
Title
morning serum cortisol
Title
skin bruising.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria: Written informed consent History of bronchial asthma for at least 6 months Pre-treatment with CFC-beclomethasone dipropionate (CFC-BDP) ≥ 1000 mcg/day or equivalent and a long-acting beta agonist (LABA) either in free or fixed combination FEV1 ≥ 80% of predicted Main Exclusion Criteria: Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids or contraindications for the use of LABAs COPD Smoking with ≥10 pack-years Pregnancy Intention to become pregnant during the course of the study Breast feeding Lack of safe contraception
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca AstraZeneca
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Altana Pharma/Nycomed
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Altana Pharma/Nycomed
City
Bruxelles
ZIP/Postal Code
1040
Country
Belgium
Facility Name
Altana Pharma/Nycomed
City
Bruxelles
ZIP/Postal Code
1190
Country
Belgium
Facility Name
Altana Pharma/Nycomed
City
Halen
ZIP/Postal Code
3545
Country
Belgium
Facility Name
Altana Pharma/Nycomed
City
Jette
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Altana Pharma/Nycomed
City
Maison-Saint-Gérard
ZIP/Postal Code
5640
Country
Belgium
Facility Name
Altana Pharma/Nycomed
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
Altana Pharma/Nycomed
City
Oostende
ZIP/Postal Code
8400
Country
Belgium
Facility Name
Altana Pharma/Nycomed
City
Turnhout
ZIP/Postal Code
2300
Country
Belgium
Facility Name
Altana Pharma/Nycomed
City
Veurne
ZIP/Postal Code
8630
Country
Belgium
Facility Name
Altana Pharma/Nycomed
City
Aix En Provence
ZIP/Postal Code
13090
Country
France
Facility Name
Altana Pharma/Nycomed
City
Beziers
ZIP/Postal Code
34500
Country
France
Facility Name
Altana Pharma/Nycomed
City
Chauny CEDEX
ZIP/Postal Code
2303
Country
France
Facility Name
Altana Pharma/Nycomed
City
Grasse
ZIP/Postal Code
6130
Country
France
Facility Name
Altana Pharma/Nycomed
City
La Rochelle
ZIP/Postal Code
17000
Country
France
Facility Name
Altana Pharma/Nycomed
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Name
Altana Pharma/Nycomed
City
Martigues Cedex
ZIP/Postal Code
13695
Country
France
Facility Name
Altana Pharma/Nycomed
City
Metz
ZIP/Postal Code
57000
Country
France
Facility Name
Altana Pharma/Nycomed
City
Montfermeil
ZIP/Postal Code
93370
Country
France
Facility Name
Altana Pharma/Nycomed
City
Montpellier Cedex
ZIP/Postal Code
34070
Country
France
Facility Name
Altana Pharma/Nycomed
City
Nice
ZIP/Postal Code
6000
Country
France
Facility Name
Altana Pharma/Nycomed
City
Nimes
ZIP/Postal Code
30900
Country
France
Facility Name
Altana Pharma/Nycomed
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Altana Pharma/Nycomed
City
Perpignan CEDEX
ZIP/Postal Code
66046
Country
France
Facility Name
Altana Pharma/Nycomed
City
Vieux Conde
ZIP/Postal Code
59690
Country
France
Facility Name
Altana Pharma/Nycomed
City
Ancona
ZIP/Postal Code
60100
Country
Italy
Facility Name
Altana Pharma/Nycomed
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Altana Pharma/Nycomed
City
Chieti
ZIP/Postal Code
66100
Country
Italy
Facility Name
Altana Pharma/Nycomed
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Altana Pharma/Nycomed
City
Livorno
ZIP/Postal Code
57124
Country
Italy
Facility Name
Altana Pharma/Nycomed
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Altana Pharma/Nycomed
City
Milano
ZIP/Postal Code
20142
Country
Italy
Facility Name
Altana Pharma/Nycomed
City
Milazzo (ME)
ZIP/Postal Code
98057
Country
Italy
Facility Name
Altana Pharma/Nycomed
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Altana Pharma/Nycomed
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Altana Pharma/Nycomed
City
Pirri-Cagliari
ZIP/Postal Code
9134
Country
Italy
Facility Name
Altana Pharma/Nycomed
City
Pordenone
ZIP/Postal Code
33170
Country
Italy
Facility Name
Altana Pharma/Nycomed
City
Roma
ZIP/Postal Code
100
Country
Italy
Facility Name
Altana Pharma/Nycomed
City
Verona
ZIP/Postal Code
30012
Country
Italy
Facility Name
Altana Pharma/Nycomed
City
Almere
ZIP/Postal Code
1315 RA
Country
Netherlands
Facility Name
Altana Pharma/Nycomed
City
Haarlem
ZIP/Postal Code
2012 CE
Country
Netherlands
Facility Name
Altana Pharma/Nycomed
City
Harderwijk
ZIP/Postal Code
3844 DG
Country
Netherlands
Facility Name
Altana Pharma/Nycomed
City
Heerlen
ZIP/Postal Code
6419 PC
Country
Netherlands
Facility Name
Altana Pharma/Nycomed
City
Helmond
ZIP/Postal Code
5707 HA
Country
Netherlands
Facility Name
Altana Pharma/Nycomed
City
Schiedam
ZIP/Postal Code
3116 BA
Country
Netherlands
Facility Name
Altana Pharma/Nycomed
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Altana Pharma/Nycomed
City
Veldhoven
ZIP/Postal Code
5504 DB
Country
Netherlands
Facility Name
Altana Pharma/Nycomed
City
Almeria
ZIP/Postal Code
4009
Country
Spain
Facility Name
Altana Pharma/Nycomed
City
Barcelona
ZIP/Postal Code
8222
Country
Spain
Facility Name
Altana Pharma/Nycomed
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Altana Pharma/Nycomed
City
Elche
ZIP/Postal Code
3203
Country
Spain
Facility Name
Altana Pharma/Nycomed
City
Guadalajara
ZIP/Postal Code
19002
Country
Spain
Facility Name
Altana Pharma/Nycomed
City
Madrid
ZIP/Postal Code
28001
Country
Spain
Facility Name
Altana Pharma/Nycomed
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Altana Pharma/Nycomed
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Altana Pharma/Nycomed
City
Madrid
ZIP/Postal Code
28047
Country
Spain
Facility Name
Altana Pharma/Nycomed
City
Requena
ZIP/Postal Code
46340
Country
Spain
Facility Name
Altana Pharma/Nycomed
City
San Sebastián
ZIP/Postal Code
20014
Country
Spain
Facility Name
Altana Pharma/Nycomed
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Altana Pharma/Nycomed
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Altana Pharma/Nycomed
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Altana Pharma/Nycomed
City
Bellinzona
ZIP/Postal Code
6500
Country
Switzerland
Facility Name
Altana Pharma/Nycomed
City
Bern
ZIP/Postal Code
3012
Country
Switzerland
Facility Name
Altana Pharma/Nycomed
City
Bruderholz
ZIP/Postal Code
4101
Country
Switzerland
Facility Name
Altana Pharma/Nycomed
City
La Chauxe-de-Fonds
ZIP/Postal Code
2300
Country
Switzerland
Facility Name
Altana Pharma/Nycomed
City
Lugano
ZIP/Postal Code
6900
Country
Switzerland
Facility Name
Altana Pharma/Nycomed
City
Münchenstein
ZIP/Postal Code
4142
Country
Switzerland
Facility Name
Altana Pharma/Nycomed
City
Münsingen
ZIP/Postal Code
3110
Country
Switzerland
Facility Name
Altana Pharma/Nycomed
City
Münsterlingen
ZIP/Postal Code
8596
Country
Switzerland
Facility Name
Altana Pharma/Nycomed
City
Zürich
ZIP/Postal Code
8048
Country
Switzerland
Facility Name
Altana Pharma/Nycomed
City
Zürich
ZIP/Postal Code
8050
Country
Switzerland
Facility Name
Altana Pharma/Nycomed
City
Zürich
ZIP/Postal Code
8063
Country
Switzerland
Facility Name
Altana Pharma/Nycomed
City
Belfast, Irland
ZIP/Postal Code
BT15 3LL
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Belfast
ZIP/Postal Code
BT7 1DA
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Bradford on Avon, Wiltshire
ZIP/Postal Code
BA15 1DQ
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Chesterfield Derbyshire
ZIP/Postal Code
S40 4TF
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Chippenham, Wiltshire
ZIP/Postal Code
SN15 2SB
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Co. Antrim
ZIP/Postal Code
BT38 8TP
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Downpatrick, Northern Ireland
ZIP/Postal Code
BT30 6HY
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Dronfield
ZIP/Postal Code
S18 1RU
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Glengormley Newtownabbey
ZIP/Postal Code
BT36 5EQ
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Glengormley
ZIP/Postal Code
BT36 4PP
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Hastings
ZIP/Postal Code
TN34 3EY
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Maidenhead, Berks
ZIP/Postal Code
SI6 2LH
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Nottingham
ZIP/Postal Code
NG3 7DQ
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Solihull
ZIP/Postal Code
B91 2JL
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Warminster Wiltshire
ZIP/Postal Code
BA12 9AA
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Watford
ZIP/Postal Code
WD25 0EA
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4510&filename=BY9010-IT-101-RDS-2006-09-21.pdf
Description
BY9010-IT-101-RDS-2006-09-21.pdf

Learn more about this trial

Efficacy of Ciclesonide and Fluticasone Propionate in Adult Patients With Moderate and Severe Persistent Asthma (18 to 75 y) (BY9010/IT-101)

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